NCT01859689

Brief Summary

This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 27, 2020

Status Verified

January 1, 2014

Enrollment Period

1.5 years

First QC Date

April 4, 2013

Last Update Submit

July 23, 2020

Conditions

Adenocarcinoma of the ProstateRecurrent Prostate CancerStage I Prostate CancerStage IIA Prostate CancerStage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Biochemical PSA control using the Phoenix definition of PSA nadir + 2

    5 years

Secondary Outcomes (5)

  • Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0

    3 months

  • Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0

    6 months

  • Changes in health related quality of life (HR-QOL) as determined by EPIC scores

    Up to 24 months

  • Changes in HR-QOL as determined by IIEF scores

    Up to 24 months

  • Changes in HR-QOL as determined by IPSS scores

    Up to 24 months

Study Arms (1)

Treatment (image-guided HDR brachytherapy)

EXPERIMENTAL

Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.

Radiation: brachytherapyRadiation: image-guided radiation therapyOther: laboratory biomarker analysis

Interventions

brachytherapyRADIATION

Undergo image-guided HDR brachytherapy

Also known as: low-LET implant therapy, radiation brachytherapy, therapy, low-LET implant
Treatment (image-guided HDR brachytherapy)
image-guided radiation therapyRADIATION

Undergo image-guided HDR brachytherapy

Treatment (image-guided HDR brachytherapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (image-guided HDR brachytherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
  • Unilateral prostate cancer as determined by prostate biopsy
  • Less than or equal to 3 positive biopsy cores
  • No biopsy core \>= 50% positive for cancer
  • Karnofsky performance status (KPS) \>= 70
  • At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
  • Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
  • Clinical stage T1c or T2a
  • PSA \< 10 ng/ml
  • Gleason score 3+3=6

You may not qualify if:

  • Patients who have previously received radiation therapy to the pelvis
  • Refusal to sign the informed consent
  • Patients who are participating in a concurrent treatment protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BrachytherapyTherapeuticsRadiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy

Study Officials

  • Mitchell Kamrava

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2013

First Posted

May 22, 2013

Study Start

March 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 27, 2020

Record last verified: 2014-01